Efficacy and Safety of Bilateral Theta Burst Stimulation for the Treatment of Auditory Hallucinations (TBS-H)

University Hospital Tuebingen

Status and phase: Completed; Phase 2

Conditions: Auditory Hallucinations

Treatments: Procedure: sham cTBS; Procedure: continuous theta burst stimulation (cTBS)

Study type: Interventional

Funder types: Other

Identifiers

NCT01478880

TBS-H 1

Details and patient eligibility

About

First clinical studies indicate an effect of repetitive transcranial magnetic stimulation(rTMS) in the treatment of auditory hallucinations (AH). However, effect size, optimal stimulation site and parameters are unclear. With this randomized, placebo-controlled clinical trial we test the efficacy and safety of bilateral continuous theta burst stimulation (cTBS), a patterned form rTMS, against auditory hallucinations. The treatment will be applied add-on to individual antipsychotic and behavioral therapy. Patients will be treated for 6 weeks each weekday (30 sessions) with 40s of cTBS (halfway between T3/P3 and T4/P4). For weeks 1-3, half of the subjects will be randomized to a sham-stimulation (coil tilted 45°). During weeks 4-6, all subjects receive real cTBS.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• auditory hallucinations at least once a week
• Schizophrenia (DSM-IV)
• stable treatment setting (in- or out-patient)
• no change of antipsychotics during and at least 1 week before treatment initiation

Exclusion criteria

• epilepsy
• benzodiazepines > 1,5mg lorazepam / d
• pregnancy
• metal parts in the brain
• cardiac pacemaker
• deep brain stimulation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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16 participants in 2 patient groups

cTBS

Experimental group

Treatment:

Procedure: continuous theta burst stimulation (cTBS)

Sham cTBS

Sham Comparator group

Treatment:

Procedure: sham cTBS